BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 12097361 · Received June 30, 2021

    Report

    Report Number
    3006630150-2021-03393
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    November 10, 2008
    Report Date
    June 30, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767688
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED SHORTLY AFTER THE PATIENT WAS IMPLANTED. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8120700, MODEL: SC-8120-70, SERIAL: (B)(4), BATCH: 192869A.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987599 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 180785 08714729767688

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention